Rehabilitation With an Obturator in Maxillary Defects

During the COVID-19 pandemic, there was a lot of reporting of COVID-19-associated mucormycosis cases. Managing this condition posed a new challenge to clinicians. Management includes therapeutic drugs and aggressive surgical debridement. Due to the unpredictability of disease prognosis and the possible recurrence of the disease, rehabilitation with delayed surgical obturators is beneficial for patients. Hence, the current study aimed to evaluate the impact of delayed surgical obturators on quality of life of COVID-19-associated mucormycosis patients post-maxillectomies

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Mucormycosis Bacterial Infections and Mycoses Infections Mycoses Zygomycosis

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mohammed A. El-Sawy

Al Mansurah, 12345, Egypt

About this study

Globally, the prevalence of mucormycosis varied from 0.005 to 1.7 per million population, while its prevalence is nearly 80 times higher (0.14 per 1000) in India compared to developed countries, in a recent estimate of year 2019-2020.

Among the medical professionals involved in managing patients with mucormycosis, maxillofacial prosthodontists are responsible for prosthetic restoration of lost oral and maxillofacial structures, helping patients to socialize and have an acceptable quality of life after surgical treatment

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

*Patients who underwent partial, subtotal and hemi-maxillectomy due to COVID-19-associated mucormycosis and who needed the prosthetic rehabilitation with delayed surgical obturator.

Exclusion criteria

Patients who are unwilling for the study.
Patients who underwent which bilateral maxillectomies.
Patients having extensive palatal mucosal loss.

Treatment and study plan

Delayed surgical obturator

Other

Prosthetic rehabilitation after surgical treatment of mucormycosis is essential for the early restoration of oral function and facial esthetics which is performed by using the surgical obturator.

Primary outcomes

Oral healthy related quality of life (oral health impact profile-49)) (OHIP-49)

Time frame: 6 months

The OHIP-14 is a self-filled questionnaire developed by Locker and Slade that focuses on 7 dimensions of impact: functional limitation (questions #1,2), physical pain (questions #3,4), psychological discomfort (questions #5,6), physical disability (questions #7,8), psychological disability(question #9,10), social disability (question #11,12), and handicap (question #13,14), with participants being asked to respond according to the frequency of impact on a 5-point Likert scale coded as never (score 0), hardly ever (score 1), occasionally (score2), fairly often (score 3), and very often (score 4). The OHIP-14 is a shorter version of the OHIP-49 but retains the original conceptual dimensions contained in the OHIP-49.

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Collaborators

Mansoura University

Registry information

Official study title

Comparison of Quality of Life After Rehabilitation With an Obturator in Maxillary Defects Due to COVID-19 Associated Mucormycosis and Oral Cancer.

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Jul 23, 2024
Registry last updated: Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting